Worldwide Recall Of Clindamycin Injection By Alvogen

The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed that Alvogen is conducting a voluntary recall of seven (7) lots of Clindamycin Injection USP ADD-Vantage Vials, manufactured for Alvogen by Hospira Inc., to the hospital/retail level.

Clindamycin Injection, USP is indicated in the treatment of serious infections caused by susceptible bacteria. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate.

Reason for recall

The recall was due to microbial growth detected during a routine simulation of the manufacturing process. This growth shows the potential for possible introduction of microorganisms into the product.

Possible associated risk

Administration of this product may cause adverse events, ranging from fever, chills and malaise, to severe adverse events including systemic invasive mycoses or systemic bacterial sepsis.

Details of affected products

Lot number

Expiration Date

Strength

NDC #

68-104-EV

07/31/2018

600mg/4mL

47781-463-69

68-105-EV

07/31/2018

900mg/6mL

47781-464-69

68-106-EV

07/31/2018

900mg/6mL

47781-464-69

73-154-EV

12/31/2018

300mg/2mL

47781-462-69

73-155-EV

12/31/2018

600mg/4mL

47781-463-69

73-156-EV

12/31/2018

600mg/4mL

47781-463-69

73-157-EV

12/31/2018

900mg/6mL

47781-464-69

Healthcare providers’ action

Healthcare providers in possession of the affected lots of product should discontinue their use and submit them to the nearest NAFDAC office.

Healthcare providers and patients should report adverse reactions associated with the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR 920543 TOLL FREE from all networks) or via
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